FDA product code QDH: Menopause Test System
QDH is the FDA product code for menopause test system. It is a Class II device, regulated under 21 CFR 862.1093 and reviewed by the Clinical Chemistry panel. Devices under QDH reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A menopause test system is an in vitro diagnostic device intended to measure hormones or other analytes in human clinical specimens as an aid in the determination of menopausal status in women.
Classification
| Field | Value |
|---|---|
| Device name | Menopause Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.1093 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for QDH devices
openFDA lists no recalls for product code QDH.
Frequently asked questions
What is FDA product code QDH?
QDH is the FDA product code for menopause test system. It is a Class II device, regulated under 21 CFR 862.1093 and reviewed by the Clinical Chemistry panel.
What device class is QDH?
Class II, regulation 21 CFR 862.1093. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QDH
- Run a recall and safety report across every QDH manufacturer
- Watch product code QDH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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